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Selling food in the US

In the US, the FDA regulates food under the Federal Food, Drug, and Cosmetic Act. It does not pre-approve labels: the business is responsible for getting them right before sale. Facilities that make or hold food register with the FDA, covered facilities keep a written food safety plan, and importers verify their foreign suppliers.

Updated · Each section links to the official source it comes from

Who writes the rules
Congress, and the FDA in regulations (21 CFR)
Label approval
None before sale: the FDA does not pre-approve labels
Major allergens
Nine, with sesame added from 1 January 2023
Facility registration
With the FDA, renewed every other year
Imports
Prior notice, and supplier verification by the importer

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Is any ingredient a food additive, or GRAS for its use? Read more
  2. 2What has to be on the label, and are the major allergens declared? Read more
  3. 3Is the facility that makes or holds it registered with the FDA? Read more
  4. 4Is there a written food safety plan where one is needed? Read more
  5. 5Which contaminant levels apply? Read more
  6. 6Does it come in from outside the US? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

Labelling and allergens

What a food label shows, and how the major food allergens are declared.

  • The FDA does not pre-approve labels for food products.
  • Labels carry a statement of identity, the net quantity, the ingredients, the name and place of business, and nutrition labelling, under 21 CFR Part 101.
  • The major food allergens are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame.
  • Sesame became the ninth major food allergen under the FASTER Act, effective 1 January 2023.

How we help: Compliant Always sets what the label has to show beside what yours shows, with the regulation for each, before a retailer or the FDA asks. Ask about this

Ingredients and food contact substances

Which substances need FDA review before use.

  • A substance intentionally added to food is a food additive, subject to premarket review and approval by the FDA, unless it is generally recognised as safe (GRAS) for its intended use or otherwise excepted.
  • Substances used in packaging that touches food have their own FDA notification programme for food contact substances.

How we help: Compliant Always keeps the evidence behind each ingredient with the product, and shows which ones rest on a GRAS basis. Ask about this

Facilities and food safety plans

Registration for the places that make or hold food, and the plans they keep.

  • Facilities that make, process, pack or hold food for consumption in the US register with the FDA, and renew every other year.
  • Covered facilities have and implement a written food safety plan, with a hazard analysis and risk-based preventive controls.

How we help: Compliant Always keeps your registration numbers and your manufacturers' certificates dated, and shows which lapse first. Ask about this

Contaminants

Levels the FDA has set for some contaminants, and the pesticide tolerances it enforces.

  • The FDA has established tolerances, action levels and guidance levels for some contaminants in food.
  • For pesticides, the FDA enforces the tolerances set by the Environmental Protection Agency.
  • Arsenic, lead, mercury and cadmium are prioritised under the Closer to Zero plan for foods eaten by babies and young children.

How we help: Upload a lab report and Compliant Always reads it line by line against the levels that apply, with the source beside each one. Ask about this

Import

What an importer owes for food made outside the US.

  • Importers are responsible for making sure imported food is safe, sanitary and labelled to US requirements.
  • The FDA does not approve importers, products, labels or shipments. Food can be imported without prior sanction if the facilities that handle it are registered and prior notice of the shipment is given.
  • Importers develop, maintain and follow a Foreign Supplier Verification Program for each food and each foreign supplier.

How we help: Compliant Always reads your foreign suppliers' documents as they arrive and keeps them with each food and supplier, the way an FSVP is organised. Ask about this

Who answers for what

WhoWhat they answer forHow we help
BrandThe label and claims, and the safety of what it sells.The label checked against the regulations, and the paperwork behind it in one place.
ManufacturerRegistration, the food safety plan and current good manufacturing practice.Specifications, test reports and certificates kept with each product, ready for a customer's form.
ImporterSupplier verification for each food and supplier, and prior notice of shipments.Foreign suppliers' documents read and dated, by food and by supplier.
Ingredient supplierThe safety basis of the ingredient, such as GRAS.Certificates and specifications collected once and shown to each customer that asks.

Federal and state

Federal agencies set the national rules. States can add their own: California's Proposition 65, for example, can call for a warning on a product sold there.

Retailers and marketplaces often ask for more than the law does, such as test reports by lot or third party certificates.

Shipping out of the US?

Exporting food from the US

Questions businesses ask

Does the FDA approve food labels before sale?
No. Under FDA law and regulations, the FDA does not pre-approve labels for food products. The business is responsible for a label that meets the requirements.
What are the major food allergens in the US?
Nine: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Sesame was added by the FASTER Act, effective 1 January 2023.
What does a US food label have to show?
A statement of identity, the net quantity of contents, the ingredients, the name and place of business of the manufacturer, packer or distributor, and nutrition labelling, under 21 CFR Part 101.
When does an ingredient need FDA review before use?
A substance intentionally added to food is a food additive and needs premarket review and approval, unless it is generally recognised as safe for its intended use or otherwise excepted.
Does a food facility have to register with the FDA?
Facilities that make, process, pack or hold food for consumption in the US register with the FDA under section 415 of the FD&C Act, and renew every other year.
What is a food safety plan?
Under the FSMA preventive controls rule, covered facilities have a written plan with a hazard analysis and risk-based preventive controls to minimise or prevent the hazards identified.
What does an importer of food into the US have to do?
Make sure the food is safe, sanitary and labelled to US requirements, give prior notice of shipments, and follow a Foreign Supplier Verification Program for each food and foreign supplier.
Does the FDA set limits for heavy metals in food?
The FDA has tolerances, action levels and guidance levels for some contaminants, and prioritises arsenic, lead, mercury and cadmium in foods for babies and young children under Closer to Zero.
Do state rules apply as well as federal ones?
They can. States can set their own rules, such as California's Proposition 65, and retailers often ask for more than the law requires.
How does Compliant Always help with selling in the US?
Our team reads the rules for the markets you sell in. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches federal sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in the US and what your paperwork needs to show.

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